Kornimate/medical-research-clean huggingface dataset:
asc - autism study

Conditions: Autism Spectrum Disorder; Gastrointestinal Dysfunction; Leaky Gut Syndrome; Mesenchymal Stromal Cells; Inflammatory Bowel Diseases

Summary: the asc - autism pilot study is a single center randomized open dose titrating phase i clinical intervention pilot trial with the aim of investigating safety and treatment effect of an allogeneic adipose tissue derived mesenchymal stromal cell product (c2c_asc) in children with autism spectrum disorder (asd) and gastrointestinal symptoms.

the asc - autism pilot study will be performed at the child and adolescent psychiatry, aalborg university hospital, denmark. 10 children aged 6-14 years with asd and gastrointestinal symptoms will be enrolled through the child and adolescent psychiatry, psychiatry clinic south, aalborg university hospital, denmark. the participants will randomly be divied into two treatment groups: 1. participant 1-5 will be treated with 1 x 1000000 c2c_ascs/kg body weight 2. participant 6-10 will be treated with 2 x 1000000 c2c_ascs/kg body weight c2c_asc treatment: the c2c_ascs product will be diluted in 50 ml isotonic saline and infused in an arm vein within 15 min. in both groups there will for each participant be a week observation for sae's related to the cell treatment before the next participant will be treated, if no sae's have been detected. the investigators hypothesize that the connection between gastrointestinal symptoms/leaky gut syndrome, increase local gastrointestinal and systemic elevated immunological and inflammatory activity, bacterial toxins in the blood and symptoms of asd in children with symptoms of leaky gut syndrome can be reduced or normalized by modulating the immunological activity and inflammation by treatment with mesenchymal stromal cells.

Eligibility criteria:
inclusion criteria: * diagnosis of autism spectrum disorder. * ongoing gastrointestinal symptoms or previous gastrointestinal symptoms which disappeared or were reduced after dietary changes. * age 6 to 14 years. exclusion criteria: * known genetic syndrome or pathogenic mutation or copy number variation associated with autism spectrum disorder. * known cns-infection (now or previously) and/or hiv positivity. * primary immunodeficiency disorder or autoimmune cytopenia. * current treatment with cytotoxic drugs or systemic administered glucocorticoids and/or immunosuppressive therapy or other antiinflammatory medication (except nonsteroidal anti-inflammatory drugs). * epilepsy or known seizure disorder (now or previously).

Keywords: gastrointestinal microbiota gut-brain axis immunomodulation
prevalence of ethnic neutropenia and duffy null phenotype in neonates

Conditions: Neutropenia (Low White Blood Cell Count)

Summary: this is a prospective observational study designed to assess the prevalence of the duffy null phenotype (associated with ethnic neutropenia) in neonates born at kaplan medical center. blood samples will be collected from umbilical cords (non-invasively) to evaluate duffy antigen expression. data on ethnicity, perinatal factors, and routine blood counts at 9-12 months (when available) will also be collected to correlate phenotype with absolute neutrophil count (anc).

this is a prospective, observational cohort study designed to evaluate the prevalence of the duffy null phenotype (fya-/fyb-) and its association with ethnic neutropenia in neonates born at kaplan medical center in israel. the duffy null phenotype has been linked to lower peripheral neutrophil counts without increased infection risk in certain ethnic groups, a condition commonly referred to as benign ethnic neutropenia. cord blood samples will be collected from approximately 1,000 neonates during routine g6pd testing. an additional 3 ml will be obtained non-invasively from the umbilical cord after labour to determine the expression of duffy antigens using serologic gel testing. parental consent will be obtained, and information regarding ethnicity and family history of neutropenia will be collected. participants identified with the duffy null phenotype will be followed through electronic health records to assess their neutrophil counts during routine blood screening at 9-12 months of age. the study will analyze associations between duffy phenotype, neutropenia prevalence, and parental ethnic origin. findings may support improved diagnostic clarity around neonatal neutropenia and help reduce unnecessary interventions in otherwise healthy infants with genetically determined low neutrophil counts.

Eligibility criteria:
inclusion criteria: * neonates born at kaplan medical center between 1.9.2024 and 31.12.2025 * parental informed consent obtained * umbilical cord blood available for routine testing exclusion criteria: * none

Keywords: neonates neutropenia duffy null associated count
minimally invasive three-dimensional knee kinematic assessment and surgical guidance using ultrasonic rigid registration

Conditions: Knee Osteoarthritis; Knee Instability; 3D Knee Kinematics; Precision of Surgical Actions; Clinical Outcomes

Summary: problem: currently, no system allows precise kinematic assessment of the knee and accurate guiding of orthopedic surgical actions in a minimally invasive fashion. however, such a system would prove useful in the clinical setting to improve the quality of surgical interventions at the knee. hypothesis: a novel knee kinematic assessment and surgical guidance tool using 3d personalized imaging and minimally invasive bony fixation allows precise kinematic assessment and surgical guidance in the routine clinical setting. objectives : * demonstrating the capacity of the system to precisely measure 3d knee kinematics * quantifying the reproducibility of the kinematic measurements * measuring the impact of knee surgical procedures on knee kinematics * assessing the correlations between measured articular kinematics and clinical results after knee surgery * integrating the novel measuring system to the surgical flow of three knee surgical procedures * quantifying the precision and reproducibility of the surgical actions guided by the system * comparing the clinical results of surgeries guided by the system to those performed with the traditional technique

a novel knee kinematic assessment and surgical guidance tool using 3d personalized imaging and minimally invasive bony fixation allows precise kinematic assessment and surgical guidance in the routine clinical setting.

Eligibility criteria:
inclusion criteria: * patients awaiting a knee surgery (total knee arthroplasty (tka), high tibial osteotomy (hto), anterior cruciate ligament reconstruction(aclr)) exclusion criteria: * active infection * atypical morphology and/or alignment of the lower limbs * knee instability (other than secondary to acl deficiency in patients awaiting aclr) * knee flexion contracture of 10 degrees or more * knee flexion of less than 120 degrees
qol assessment in breast cancer patients with radiation-induced telangiectasias treated with the pulsed dye laser

Conditions: Breast Cancer; Radiation-Induced Telangiectasias

Summary: the purpose of this study is to see how the look of telangiectasias (small dilated blood vessels) on radiated breast skin when altered by the pulsed dye laser affects a patient's overall well being. patients will have a set of treatments with a pulsed dye laser. this is a laser that targets red blood vessels and delivers heat causing the telangiectasias to become smaller and less visible. the laser has been used safely to treat telangiectasias on the skin of patients who received radiation for breast cancer. patients in the study will be asked to complete a questionnaire asking how they feel about the telangiectasias, their radiated skin and its effect on their daily lives. the questionnaire will be given at every visit. the improvement in the look of patients' radiated skin will also be compared to answers to the questionnaire. we hope the study will improve our understanding of how patients feel about the long term effects of radiation on their skin.


Eligibility criteria:
inclusion criteria: * locally advanced breast cancer patients treated with surgery and adjuvant radiation * telangiectasias in the radiation field of the treated breast * patients 18 years or older exclusion criteria: * non english speaking * current oral steroid use or receiving daily therapeutic anticoagulation (e.g. coumadin, lovenox) * breast/s reconstructed with implant in the area of previous radiation * pregnancy or lactation * previous laser treatment of telangiectasias * presence of a sun tan in the area * fitzpatrick skin types v, vi

Keywords: quality of life assessments radiation telangiectasias 13-013
study of oral topotecan with bevacizumab for recurrent small cell lung cancer

Conditions: Recurrent Small-cell Lung Cancer (SCLC); Lung Cancer, Small Cell

Summary: combination of hycamtin (topotecan) and avastin (bevacizumab) could allow killing of both endothelial and neoplastic cells. we postulate that addition of bevacizumab to topotecan will increase delivery of topotecan to tumor cells and may enhance activity of topotecan in patients with previously treated small cell lung cancer and improve progression free survival.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of sclc. * first recurrence of sclc after therapy with one prior chemotherapy regimen at initial diagnosis. * relapsed sclc of any duration (both sensitive and resistant relapse). * ecog performance status of \</= 2. * adequate bone marrow reserve, hepatic, renal, and cardiovascular function. * no prior therapy with bevacizumab or any other vegf inhibitor or topotecan exclusion criteria: * uncontrolled emesis, regardless of etiology. * active uncontrolled infection. * gi conditions or drugs that could impact absorption of oral topotecan. * known hypersensitivity to any component of topotecan capsule or compounds chemically related to topotecan. * uncontrolled hypertension with bp\>150/100. * prior h/o hypertensive crisis or encephalopathy. * nyha grade ii or greater congestive heart failure. * h/o myocardial infarction within 6 months. * h/o stroke or tia within 6 months. * h/o thrombotic or hemorrhagic disorders. * clinically significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months. * major surgical procedure, open biopsy, or significant traumatic injury within 28 days. * anticipation of need for major surgical procedure during the study. * minor surgical procedures within 7 days prior to treatment start (placement of vascular access devices is permitted). * h/o abdominal fistula, gi perforation, or intra-abdominal abscess within prior 6 months. serious, non-healing wound, active ulcer, or untreated bone fracture. - h/o hemoptysis within prior 1 month. * concurrent radiotherapy. * h/o whole lung radiation within 90 days prior to start of treatment. * presence or h/o central nervous system or brain metastases. * h/o another malignancy other than sclc. * concurrent chemotherapy, immunotherapy, or investigational therapy for the treatment of small cell lung cancer.

Keywords: bevacizumab small cell lung cancer (sclc) topotecan
enhancing sexual safety: couples' communication and hiv testing among ymsm

Conditions: HIV/AIDS; HIV Infections

Summary: the purpose of this study is to compare different ways to deliver the couples hiv testing and counseling (chtc) intervention that is suited for adolescents and young adults.

investigators will conduct a comparative effectiveness trial (cet) of chtc for adolescent-age (15-24 years) same-sex male couples. this design tests the added benefits of adjunct intervention components delivered prior to receipt of chtc-assertive communication training (act) videos viewed by the individual or couple together and individually delivered motivational interviewing-based communication skills training (mi-cst). these target the development of communication skills necessary to participate fully in hiv prevention and sexual safety discussions inherent to chtc. youth will be randomized to receive one of two conditions: condition 1: watch videos on act, participate in communication skills training (mi-cst), and complete an individual hiv test, or if participating as a couple will receive chtc, and condition 2: individual hiv testing (ihtc) as usual. youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. youth in this cet will complete follow-up assessments at 1, 3, and 6 months.

Eligibility criteria:
inclusion criteria: * at least one partner must be hiv-negative or status unknown * the index partner must be 15-24 years old * ymsm under age 18 must have an age concordant partner to participate in this study, i.e., minors may only participate in the study with a partner within 2 years of age of the minor subject's age. the age concordant partner must be at least fifteen years old. * index partner must be sexually active (any activity that could lead to orgasm) * currently seeing someone, dating, experimenting with relationships or in a relationship * have had sex, hooked up with or made out with that person * both partners must be able to communicate in english. * live in or near new york city or detroit or san diego * gender identity as male or nonbinary, genderqueer, agender or gender noncomforming exclusion criteria: * unstable, serious psychiatric symptoms * current suicidal/homicidal ideation * current or prior intimate partner violence (ipv) on the part of either relationship partner * if either participating partner felt pressured or coerced to participate in the study or felt anyone made them feel they had to participate in they study when they did not want to.
comparison of init versus nmr in patients with deep gluteal syndrome

Conditions: Deep Gluteal Syndrome

Summary: rationale of this research is to evaluate the outcome of comparison of integrated neuromuscular inhibition technique versus neuromuscular reeducation on pain in patients with deep gluteal syndrome. the significance of this study is to identify which technique is superior in alleviating the symptoms of deep gluteal syndrome. this study will help gather evidence on the practice of incorporating trigger point therapy in the treatment of deep gluteal syndrome.

deep gluteal syndrome is a common buttock and posterior hip pain caused by entrapment of the sciatic nerve in the posterior hip region. nonoperative therapy involves treating the entrapment location, using rest, anti-inflammatories, musclerelaxants, and physical therapy to relieve compression. the purpose of the study was to evaluate the effects of integrated neuromuscular inhibition technique versus neuromuscular reeducation technique on pain in subject with deep gluteal syndrome. it was a randomized, controlled trial, conducted among deep gluteal syndrome patients. sample size was 54 by using g power tool software. participantswere randomly assigned to the intervention or control group after a baseline assessment with a lottery ticket and an opaque envelope. all participants in both groups were evaluated on baseline and 12 th session.

Eligibility criteria:
inclusion criteria: both genders age: 30-50 years pain due to a non-discogenic sciatic nerve entrapment in the sub gluteal space pain, tightness and dysesthesias in the buttock area, posterior thigh buttock pain aggravated with prolong sitting (\&gt;20-30 min) buttock pain aggravated when sitting with limited straight leg raising ability (seated piriformis test) pain with the passive internal rotation of hip (freiberg sign) pain increase in flexion, adduction and internal rotation (positive fair test) exclusion criteria: * patient with any intrinsic etiology such as hemarthrosis, rheumatoid arthritis, infection or gout patient with any severe trauma, fractures dislocation, subluxation or ligament injury any pathology or recent injury around the hip, sacroiliac joint, or lumbar spine limb length discrepancy recent buttock trauma and bladder/bowel dysfunction

Keywords: trigger point nmr init deep gluteal syndrome
an exercise facilitator to activate simple training programs in the dialysis center

Conditions: Chronic Kidney Disease Stage 5 on Dialysis

Summary: low physical activity levels and progressive poor functional capacity affect quality of life and clinical outcomes of chronic kidney disease (ckd) patients. interventions to prevent the functional decline associated with a sedentary lifestyle or to relief from deconditioning are crucial, considering the significant beneficial effects of exercise in all ckd patients, especially in end-stage kidney disease patients (eskd). unfortunately, physical and psychological barriers to exercise are present and physical activity management is not routinely addressed in the patient's care. for the first time the project aims to test the impact of the regular presence of an exercise specialist in the nephrology unit. this facilitator, evaluating capacity, motivation and preferences of each patient, will design tailored solutions and assess the related outcomes. several design of training programs will be proposed to dialysis patients, that can choose the exercise option that best fits their needing. the study will determine the feasibility of the project, the patients' adherence and the effectiveness of the programs proposed to improve the patients' lifestyle.

the assumption underlying the project is that a wider participation to physical activity programs (paps) of eskd patients may be facilitated by the presence in the renal unit of an exercise specialist able to design tailored programs and that this intervention may lead to measurable benefits on physical fitness, quality of life and general health. the possible different solutions offered by an expert of exercise in chronic diseases might reduce most of the barriers to exercise responsible of the sedentary behavior of the eskd patients. aim of the project is to test the impact of the regular presence of this facilitator in a nephrology unit in terms of applicability and feasibility as well to identify the preferred and the most effective pathways for the patients. the identification of a novel cost-effective intervention may represent an important step to manage the change of lifestyle of eskd patients, to slow down their physical and qol decline and to reduce hospitalizations and negative outcomes affecting this population.

Eligibility criteria:
inclusion criteria: * male and females aged \> 18 years; * ability to walk assisted or unassisted at least for 6 meters; * cognitive functioning to give informed consent identified by a mini mental status examination score ≥18/30. exclusion criteria: * severe cardio-respiratory (e.g. unstable angina; severe heart failure identified by new york heart association class iii or iv); * neurological or musculoskeletal conditions (e.g. above knee amputation) contraindicating or inhibiting exercise training.

Keywords: exercise rehabilitation exercise testing
cpct-05 biopsy protocol patient selection

Conditions: Solid Tumors; Metastatic Disease

Summary: our knowledge on the genetic mutations in cancer is rapidly expanding and we are increasingly testing drugs in mainly metastatic cancer patient populations with rare mutations. successful examples of this new strategy are alk inhibitors in alk translocated nsclc (less than 5% frequency) and egfr inhibitors in egfr mutant nsclc (approximately 5% frequency). selecting molecularly stratified patient populations for studies benefits the patient as it increases the odds of obtaining benefit from experimental treatment, especially in early clinical trials. moreover it increases the speed and efficacy of drug development as signs of efficacy are picked up in earlier phases. therefore, broad screening of molecular lesions in the tumors of patients that are being considered for participation in trials is crucial. this pre-selection increases our ability to perform several trials in parallel and thus include more patients in more meaningful trials. with the still dismal prognosis of patients with metastatic cancer, increasing the accrual rate to pivotal trials in selected patient populations is a key factor in improving prognosis. the advent of next generation sequencing (ngs) platforms enables us to probe a limited number of cancer related genes within 2-4 weeks. we have extensively piloted this approach and are now able to deliver clinically meaningful turn-around-times. this development enables us to use this technology to enrich clinical trials using targeted therapies for patients with specific mutations. we will obtain tumor biopsies of a metastatic or locally advanced lesion and a peripheral blood sample from all patients included in the trial; the biopsies to obtain information on the tumor related genetic mutations (mutational profile) and the blood samples to assess each patient's germline dna background variation. as patients will be asked to undergo an invasive procedure it is important to address the potential safety issues. review of the literature and our own experience show that tumor biopsies can be performed with only minor complications and acceptable risks. we will recruit patients with metastatic or locally advanced solid tumors from patients that can potentially be included in clinical trials.


Eligibility criteria:
inclusion criteria: * locally advanced (incurable) or metastatic cancer from a histological or cytological proven solid tumor * indication for systemic treatment with anti-cancer agents (with no treatment options with curative intent) * measurable locally advanced (incurable) or metastatic lesion(s), according to recist 1.1 criteria. * safe biopsy of a metastatic or locally advanced lesion possible * no contraindications for lidocaine (or its derivatives) and/or midazolam and/or phentanyl * adequate organ function * who performance status 0-2 * age \> 18 yr * expected adequacy to follow up * written informed consent exclusion criteria: • if one or more of the above mentioned inclusion criteria is not met